Q:I have an agency/company/individual interested in funding my work. What is the first step?

A:

Assistance in developing the written portion of the proposal, formulating ideas, as needed: Delia Gallinaro, or phone (936) 294-3760

Assistance with budget development, proposal routing, proposal submission: Dee Myall, or phone (936) 294-4032 (Due to the fact that the award will be made to the University and not to the PI, University policy requires the proposal to be reviewd and approved before it is submitted.)

Q: Why am I required to submit my proposal through ORSP?

A: Proposals must be routed so that the signatures of the researchers and the Chair/Dean can be obtained. Your Chair/Dean provides the technical review of the proposal. Your Chair/Dean also needs to know how much time you are proposing to commit to research and to approve any release time or reduction in teaching load. Your Chair/Dean must approve any cost-sharing or matching funds prior to submission.

In addition, the federal government has rules that educational institutions must follow in the costing of their proposals. Some costs are allowable and others are not. There is also a requirement to be consistent in the way that costs are proposed and reported. ORSP will prepare your proposal budget according to the federal or other sponsor's general guidelines, the specific requirements of the program and according to SHSU policies and procedures.

Q: Why do I need ORSP to prepare/verify my budget?

A: ORSP will verify that proper salaries/wages, fringe and indirect are appropriately calculated before a proposal is submitted. This should prevent any miscalculations affecting your bottom dollar. In addition, ORSP will identify which standard budget categories are appropriate for your proposed funding. This will ensure accuracy when post-award personnel are notified of your award and loads your funds into the Grant Accounting System.

Q: What is the signature process for the proposal routing form?

A: The signature process for the proposal routing form is as follows:

PI(s)' and Co-PI(s)' Department Chair(s) Dean(s)

ORA

B: ORA will obtain the remaining signatures:

ORSP (applies to all proposals)

Provost (if matching funds are involved)

President (if over $750K)

IRB FAQ

Q: What is the
procedure for IRB application submissions?

A: The SHSU
in-house application system for Institutional Review Board (IRB) reviews, which
can be accessed from any computer, is found on SamWeb. The pathway for accessing
the system follows: SamWeb >
Miscellaneous > Forms >
IRB Application.

The following documentation could
potentially be required for IRB review:

Q: What documentation is required for a continuing IRB review of
my research?

A: For the IRB to meet its
regulatory obligations (45 CFR §46.109), SHSU’s IRB requires
the following documentation for a continuing IRB review of research:

A brief project summary (this could be included (a) as part
of a progress report described in the next bullet, (b) provided as a separate
document, or (c) be addressed by referencing other documents made available to
the IRB, including the informed consent document(s));

The number of subjects accrued (for multicenter research studies, the number
of subjects accrued at the local institution and the number accrued study-wide,
if available, should be provided);

A brief summary of any amendments to the research approved by the IRB since
the IRB’s initial review or the last continuing review;

Any new and relevant information, published or unpublished, since the last
IRB review, especially information about risks associated with the research;

A summary of both any unanticipated problems and available information
regarding adverse events (the amount of detail provided in such a summary will
vary depending on the type of research being conducted; in many cases, such a
summary could be a brief statement that there have been no unanticipated
problems and that adverse events have occurred at the expected frequency and
level of severity as documented in the research protocol and the informed
consent document)

A summary of any withdrawal of subjects from the research since the last IRB
review, and the reasons for withdrawal, if known; and

A summary of any complaints about the research from subjects or others since
the last IRB review;

The latest version of the IRB-approved protocol and informed consent
document(s);

Any proposed modifications to the informed consent document or
protocol;

Any other significant information related to subject risk.

Q: What is the
procedure to follow for informing the IRB of significant changes to my
already-approved IRB protocol?

A: You will need
to submit an Amendment to your already approved IRB protocol. Click on the link
below to start the Amendment process: